It was reported by the affiliate in japan that during a meniscorrhaphy treating meniscus tear (b)(6) 2022, it was observed that the sheath part on the truespan meniscal repair system plga 24 degree device split vertically, and the 2nd anchor was not fired properly.According to the report, the sheath part probably hit the joint as it entered the joint, but it was not certain.The surgery was completed successfully with no surgical delay.This surgery was an infection case.The surgeon used this product for the first time.There was no harm to the patient.The device was brand new and the first use when the issue occurred.No additional information was provided.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Initial reporter occupation: reporter is a j&j employee.The complaint device is not being returned, therefore unavailable for a physical evaluation.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.A manufacturing record evaluation was performed for the finished device lot number (9l35920), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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